12-month Effects of Stabilized Hyaluronic Acid Gel Compared With Saline for Rejuvenation of Aging Hands

March 2015 | Volume 14 | Issue 3 | Original Article | 288 | Copyright © March 2015


Elena I. Gubanova MD,a,b Polina A. Starovatova MD,a,b Maria Y. Rodina MDc

aVallex M, Clinic of Preventive Medicine, Moscow, Russia
bDepartment of Skin and Venereal Diseases, Medical Institute of Postgraduate Medical Moscow National University of Food Production,
Moscow, Russia
cEvaluation Center, DME, L'Oreal, Moscow, Russia

Abstract
In this evaluator-blind, placebo-controlled study, microinjections of stabilized hyaluronic acid (HA) gel for rejuvenation of aging hands were evaluated. Patients received three injections of 1.0 ml HA gel (20 mg/ml HA) in the dorsum of one hand and 1.0 ml saline in the other, over 3 months (M). Treatments were compared up to M03; comparisons with Day 1 (D01) were made up to M05 and M12 (extension study). Efficacy was evaluated by patients and investigators using the Global Aesthetic Improvement Scale (GAIS). Self-assessment questionnaires, biomechanical measurements, and adverse events (AEs) were analyzed.
Thirty women (mean age: 53 years) provided data up to M05. At M03, HA gel treatment improved hand skin condition in all patients versus D01, according to the GAIS; improvements were sustained to M12. Mean patient scores at M01–M03 were significantly higher for HA gel than for saline (P<0.05). Self-assessment questionnaire grades up to M03 were generally significantly better for HA gel versus saline (P<0.05); grades were maintained to M12. Statistically significant improvements with HA gel in hydration and elasticity was demonstrated at M03, compared with D01 and saline (P<0.05), and in terms of skin roughness versus D01. Maximum roughness (P<0.05) and waviness (P<0.01) were significantly improved versus saline.
All AEs were mild and anticipated, with no serious AEs.
Overall, HA gel injections were generally well tolerated and efficacious for rejuvenation of aging hands compared with saline. Sustained improvements at 12 months compared with baseline indicate that efficacy could be maintained long term.

J Drugs Dermatol. 2015;14(3):288-295.

INTRODUCTION

Aging of the hand includes atrophy of the skin and subcutaneous tissue, dryness and sagging of the skin, prominence of veins and tendons, hyperpigmentation and keratosis.1-3 Age-related changes are often perceived as aesthetic flaws, prompting patients to seek cosmetic help. Despite this, the hands receive less attention compared with the face in aging and rejuvenation studies.
Interest in injections with stabilized hyaluronic acid (HA) gel products, calcium hydroxyapatite and lipofilling has increased.4-7 Microinjections of stabilized HA gel have been shown to rejuvenate the skin of the face, upper arm and hands.8-12 In the hand, intradermal injections of stabilized HA had better effects in terms of elasticity and roughness compared with non-stabilized HA.10 However, the follow-up period was only 6 months (4 months after the last treatment).
In this study, we evaluated the use of microinjections of stabilized HA gel and a whitening cream to improve the quality and color of the skin of the hand. We included saline as a comparator treatment to differentiate the effects of the HA gel from any effects induced by the injection procedure.

METHODS

Study Design

This evaluator-blind, placebo-controlled, comparative prospective clinical study was carried out between May 2012 and June 2013, in Moscow, Russia. The objectives were to assess the efficacy of microinjections of HA gel on hand skin quality and biomechanical properties. Comparisons were made against the contralateral hand, which was injected with saline. A twice-daily whitening cream was also applied to both hands to assess its efficacy on skin color. Eligible patients provided written informed consent and completed the first injection treatment session at Day (D) 01. Patients returned for a second and third injection at Month (M) 01 and M02, respectively. Follow-up was conducted at M03, M04, and M05. The study was extended to include a M12 assessment for the hand originally treated with HA gel; no further treatments were received during the extension and only comparisons with baseline were made at M12. All study procedures were carried out in accordance with the Declaration of Helsinki.

Patients

Caucasian women aged 40–65 years with age-related changes to the skin of the hands (prominence of veins and tendons, hyperpigmentation, roughness) and dryness (hydration of skin
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